Court Orders More Access to Morning-After Pill
The FDA has advised the maker of levonorgestrel-the emergency "morn- ing after" contraceptive pill known as Plan B-that the product can now be marketed to 17-year-olds without a prescription.
The FDA action follows a recent US District Court ruling in New York. In that ruling, the judge ordered the FDA to review its 2006 decision making Plan B available only to women aged 18 and older without a prescription. In opting not to challenge the federal court's ruling, the agency noted that it is consistent with scientific findings made in 2005 by the Center for Drug Evaluation and Research.
A number of health advocates, including the World Health Organization, support the use of levonorgestrel as a backup method for women of any age needing emergency contraception. Nancy Northup, president of the Center for Reproductive Rights, commended the agency for "taking swift action to ensure that its decisions on Plan B are based solely on the drug's safety and efficacy."
Not everyone is happy with the court's ruling and the FDA's decision not to appeal it, however. "This decision is driven by politics, not what is good for patients or minors," noted Wendy Wright, president of Concerned Women for America. "Parents should be furious at the FDA's complete disregard for parental rights and the safety of minors."
Hospitals Move into Retail Clinics
The surge of walk-in clinics at drugstores and supermarkets has prompted growth in another area-hospitals.
Across the United States, hospital clinics are now affiliated with >25 Walmart clinics. The company plans to open more hospital-connected clinics in the coming months. The Cleveland Clinic has entered into a clinical collaboration with some CVS/pharmacy MinuteClinics in northeastern Ohio.
The Mayo Clinic is now in the mix, with one Express Care clinic at a supermarket in Rochester, Minnesota, and a second location at a shopping mall. The Mayo Clinic said it made the move toward hospital-connected clinics after employees and patients expressed interest in more convenient treatment for minor medical problems. "We think of ourselves as a new model of care; we meet our patients at least halfway," said David Herman, MD, a Mayo executive who supervises the 2 retail clinics.
Data have shown that more individuals prefer the clinics because of cost and convenience.
Pharmacies Fight New DMEPOS Rule
Chain and independent pharmacy advocates are praising legislation introduced in the House of Representatives and Senate exempting state-licensed retail pharmacies from a regulation requiring suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) to obtain a $50,000 surety bond in order to serve Medicare beneficiaries.
The Preserve Patient Access to Reputable DMEPOS Providers Act of 2009 (HR 1970, S 956) was introduced in the House by Reps Zack Space (D, OH) and Jo Ann Emerson (R, MO) and in the Senate by Sens Jon Tester (D, MT) and Pat Roberts (R, KS). The bipartisan measures are in response to a final rule from the Centers for Medicare&Medicaid Services that sets an October 2, 2009, deadline for pharmacies to obtain the surety bond.
"The DMEPOS surety bond could create a financial burden on our nation's community pharmacies-in the middle of an economic recession-and directly impact the patients they treat," said Steve Anderson, IOM, CAE, president and chief executive officer of the National Association of Chain Drug Stores.
CDC Urges Drugs for Swine Flu in Pregnant Women
The Centers for Disease Control and Prevention (CDC) recommends Tamiflu (osteltamivir phosphate) be given to any pregnant patient with flu symptoms and a history of probable contact with anybody with the influenza virus H1N1 (swine flu).
Whereas the CDC does not normally recommend treatment with the antiviral drug, pregnant women who contract swine flu face a greater risk of pneumonia, dehydration, and premature labor. The agency is urging quick action because a positive test for swine flu can take days. In addition to Tamiflu, Relenza (zanamivir) is approved to treat the condition. As of press time, 47 states had cases of swine flu with >4000 confirmed and probable cases and 4 deaths. The virus was first detected in April.
Kudos for Pharmacy Advocates
Ed Cohen, PharmD
Joseph Fink, BSPharm, JD
Pharmacy Times Board of Advisors member Ed Cohen, PharmD, and monthly Pharmacy Law columnist Joseph Fink, BSPharm, JD, have recently been recognized for leadership and advocacy in their fields.
Cohen, manager of immunization clinical services for Walgreens, was honored by the American Pharmacists Association, Academy of Practice & Management (APhA-APPM) at the APhA's recent annual meeting in San Antonio, Texas. APhA-APPM Distinguished Achievement Awards pay tribute to individuals who have made significant or sustained contributions to the provision of pharmaceutical care in selected practice areas. Cohen's award recognizes his work in the area of administrative practice.
Fink recently received the Robert G. Zumwinkle Student Rights Award from the Student Government Association of the University of Kentucky, where he is professor of pharmacy law and policy. The award honors a faculty member, staff member, or student who has protected, enforced, or furthered student rights. He has served as the University Hearing Officer and Chair of the University Appeals Board for 10 years. New Chronic Pain Guidelines Suggest Opioids for Elderly
A major change in the American Geriatrics Society's (AGS) pain management guidelines for seniors aged 75 and older calls for very limited use of nonsteroidal anti-inflammatory drugs (NSAIDs). Original guidelines recommended seniors use OTC or prescription NSAIDs or cyclo-oxygenase-2 (COX-2) inhibitors (ie, aspirin or ibuprofen) before being prescribed an opioid drug.
The panel recommends that NSAIDs and COX-2s be considered "rarely" and "with extreme caution." The guidelines suggest that all patients with moderate- to-severe pain or diminished quality of life due to pain should be considered for opioid therapy, which may be safer for many patients than long-term use of NSAIDs. The revamped guidelines will be published in the August 2009 issue of the Journal of the American Geriatrics Society.
The guidelines were updated in 2002, but since then, new drugs and treatment approaches have emerged and pain management strategies more thoroughly evaluated. As a result, the AGS convened with a Panel on Pharmacological Management of Persistent Pain in Older Persons to address the guidelines again with an eye on pharmacotherapy. The panel focused on this patient population because this group tends to be more frail and have multiple chronic illnesses.
NCPA Launches Rx Disposal Program
In an effort to help protect waterways from contamination of pharmaceuticals, the National Community Pharmacists Association (NCPA) is doing its part with its new Prescription Disposal Program. The program offers information and resources for pharmacies to create prescription drug disposal programs for consumers.
Association members will receive access to a free online Prescription Disposal Program toolkit including planning guides, customizable marketing and publicity materials, as well as resource links and information on state waste programs and potential reverse distribution partners that provide a variety of disposal options.
Utah Develops Guidelines for Pain Meds
With more Utah residents dying as a result of prescription pain medication overdoses than car accidents, the Utah Department of Health (UDOH) recently finalized a draft of clinical guidelines the agency hopes will assist health care professionals in prescribing these drugs.
The guidelines, available at www.useonlyasdirected.org, include key recommendations and >20 tools providers may use in their practices to implement them. Included are tools for monitoring patients on opioids, screening for risk of opioid-related abnormal behaviors, sample treatment plans, and dosing guidelines.
Last year, UDOH launched the Use Only as Directed campaign to educate residents about the dangers of prescription drug misuse. The goal is to reduce the number of unintentional Rx pain medication overdoses in the Beehive State by 15% this year. Utah is the second in the nation to develop guidelines for health care professionals to follow when prescribing pain medications for the treatment of chronic and acute pain.